Published by IRDiRC
Research and Drug DevelopmentRare DiseasePatient RegistryFAIRGuidelineLack of ultimate data use in rare disease created many silos slowing down development. The FAIR is coming to bridge this gap by proving essential guidelines for optimal data use.
View this resource Bookmark this resourcePublished by IRDiRC
Regulatory AffairsPatient DataEarly Access SupportPatient RegistryScientific AdvicePatient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the Safety of medicines
View this resource Bookmark this resourcePublished by IRDiRC
Agency For Medical Research and DevelopmentJapanInitiative on Rare DiseasesClinical Innovation NetworkCinical TrialResearch and Drug DevelopmentClinical DevelopmentPatient RegistryJapan Agency for Medical Research and Development (AMED) leads the Initiative on Rare and Undiagnosed Diseases (IRUD) program. The program provides patients across Japan suffering from undiagnosed diseases with a diagnostic strategy that involves genetic analysis
View this resource Bookmark this resourceRaDaR, formerly known as the Global Rare Diseases Registry Data Repository program, aims to define best practices for patient registries. RaDaR also strives to identify and adopt standards to support high-quality registries for rare diseases therapeutics development.
View this resource Bookmark this resourcePublished by IRDiRC
DatabaseResearch and Drug DevelopmentPatient RegistryRegistry for Rare DiseaseRegistries collect information on patients afflicted by a particular disease or group of diseases. By combining data on as many patients as possible, at the regional, national, European or global level, the potency of the data increases exponentially
View this resource Bookmark this resourcePublished by IRDiRC
Research and Drug DevelopmentRare DiseasePatient RegistryFAIRGuidelineLack of ultimate data use in rare disease created many silos slowing down development. The FAIR is coming to bridge this gap by proving essential guidelines for optimal data use.
View this resource Bookmark this resourcePublished by European Medicines Agency
Human Medicinal ProductsPatient RegistryReal World EvidenceReal Word DataRegistry-Based StudyFeasibility AnalysisThe objective of this Guideline is to provide recommendations on key methodological aspects that are
specific to the use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs)
planning to conduct registry-based studies
